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Completed

NCT Number: NCT00850564

Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will increase GH pulse height and will not affect insulin sensitivity.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

MGH

Boston, Massachusetts, 02114, United States

About this study

The primary objective of this study is to determine the effects of growth hormone releasing hormone (Tesamorelin) on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Healthy male subjects will receive 2mg Tesamorelin, subcutaneously, daily for two weeks. At baseline and after two weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp. Subjects will then stop the Tesamorelin and will return for an identical assessment after a 2 week withdrawal period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men aged 18-60 years
  • BMI > 20kg/m2 and <35kg/m2

Exclusion criteria

  • Use of anti-diabetic agents, Megace, testosterone or any steroid use within 6 months of the study
  • Use of GH or growth hormone stimulating peptides within six months of starting the study
  • Change in lipid lowering or antihypertensive regimen within 3 months of screening
  • Fasting blood sugar > 126 mg/dL, SGOT > 2.5 times ULN, Hgb < 12.0 g/dL, creatinine > 1.4 mg/dL
  • Carpal tunnel syndrome
  • Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
  • For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5 ng/mL
  • Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis
  • Weight < 110 lbs.

Treatment and study plan

Growth Hormone Releasing Hormone (Tesamorelin)

Drug

Tesamorelin 2mg subcutaneous daily x 2 weeks

Other names: Tesamorelin

Primary outcomes

  1. Mean Overnight Growth Hormone

    Time frame: at 2 weeks (i.e., after 2 weeks of treatment)

    Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment.

Secondary outcomes

  1. Insulin Stimulated Glucose Utilization

    Time frame: at 2 weeks (i.e., after 2 weeks of treatment)

    Insulin stimulated glucose uptake (M) is the amount of glucose (measured in mg per kg body weight per minute) taken up during the steady state period of a euglycemic hyperinsulinemic clamp. This measure was calculated for minutes 100-120 of euglycemic hyperinsulinemic clamp procedure at 2 weeks (i.e., after 2 weeks treatment with growth hormone releasing hormone). The measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the measurement before treatment.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 25, 2009
Registry last updated
Apr 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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